COMMISSION DELEGA TED REGUL ATION (EU) 2019/625 
of 4 March 2019 
supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with 
regard to requirements for the entr y into the Union of consignments of certain animals and goods 
intended for human consumption 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 Marc h 2017 on 
official controls and other official activities performe d to ensure the application of food and feed law, rules on animal 
health and welfa re, plant health and plant prote ction products, amending Regulations (EC) No 999/2001, (EC) 
No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and 
(EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) 
No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and 
repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, 
Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council 
Decision 92/438/EEC (Off icial Controls Regulation) (1), and in particular Article 126(1) thereof, 
Whereas: 
(1)  Regulation (EU) 2017/625 lays down rules for the performa nce of official controls and other official activities by 
the compet ent author ities of the Member States, including for the establishment of requirements to be fulfilled 
for the entr y into the Union of consignments of animals and goods from third countr ies or regions thereof and 
official controls performe d on such consignments that are intended for human consum ption in order to ensure 
that they compl y with Union legislation in the area of food and food safety . 
(2)  Regulation (EU) 2017/625 provides a legal basis for delegat ed acts to be adop ted in order to supplement the 
conditions laid down in that Regulation for the entr y into Union of certain animals and goods. These additional 
requirements include guarantees concer ning the verification of compl iance with: 
—  the measures to monit or substances and groups of residues in animals and goods intended for human 
consump tion in accordance with Council Directive 96/23/EC (2); 
—  the rules for the prevention, control and eradication of transmissible spongif orm encephalopathies (TSEs) in 
live animals and products of animal origin in accordance with Regulation (EC) No 999/2001 of the European 
Parliament and of the Council (3); 
—  the general principles and requirements govern ing food in general and food safety in particular at Union and 
national level in accordance with Regulation (EC) No 178/2002 of the European Parliament and of the 
Council (4); 
—  the general rules for food business operat ors on the hygiene of foodstuffs in accordance with Regulation (EC) 
No 852/2004 of the European Parliament and of the Council (5); 17.5.2019 L 131/18 Official Jour nal of the European Union EN     
(1)OJ L 95, 7.4.2017, p. 1. 
(2)Council Directive 96/23/EC of 29 Apr il 1996 on measures to monitor certain substances and residues thereof in live animals and 
animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (OJ L 125, 
23.5.1996, p. 10). 
(3)Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, 
control and eradication of certain transmissible spongif orm encephalopathies (OJ L 147, 31.5.2001, p. 1). 
(4)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles 
and requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safet y 
(OJ L 31, 1.2.2002, p. 1). 
(5)Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 Apr il 2004 on the hygiene of foodstuffs (OJ L 139, 
30.4.2004, p. 1). —  the specifi c rules on the hygiene of food of animal origin for food business operators in accordance with 
Regulation (EC) No 853/2004 of the European Parliament and of the Council (6); 
—  the specifi c rules on official controls and for action taken by the compet ent author ities in relation to 
production of products of animal origin intended for human consump tion in accordance with Commission 
Delegat ed Regulation (EU) 2019/624 (7) and Commission Imp lementing Regulation (EU) 2019/627 (8). 
(3)  Regulation (EC) No 854/2004 of the European Parliament and of the Council (9) laid down specifi c conditions 
for the entr y into the Union of products of animal origin intended for human consump tion, while Regulation 
(EC) No 882/2004 of the European Parliament and of the Council (10) laid down the general conditions for the 
entr y into the Union of food. Regulation (EU) 2017/625 lays down rules in areas currently covered by those two 
Regulations and it repeals them and replaces them with effect from 14 December 2019. 
(4)  The requirements laid down in this Regulation should ensure a continuation of the requirements laid down in 
Regulations (EC) No 854/2004 and (EC) No 882/2004 to ensure a high level of prote ction of health and in order 
to a avoid a disruption of the entr y into the Union of consignments of certain animals and goods intended for 
human consum ption. At the same time the exper ience gained in the application of the rules laid down in those 
two Regulations should be taken into account using a risk-based approach . 
(5)  Regulation (EC) No 853/2004 lays down requirements for food business operators impor ting products of animal 
origin into the Union. According ly, the additional requirements laid down in this Regulation for official controls 
should be consistent with those already laid down in Regulation (EC) No 853/2004. 
(6)  Commission Regulation (EU) 2017/185 (11) provides for deroga tions from Regulation (EC) No 854/2004 
concer ning public health requirements for imports of certain products of animal origin (such as insects and 
reptile meat) and food containing both products of plant origin and processed products of animal origin 
(com posite products) until 31 December 2020. In order to ensure a high level of prot ection of health, 
requirements for the entr y into the Union of such products should also be laid down before the expir y of the 
transitional measures in order to verify compl iance with Union rules covering these products. 
(7)  Insects are increasing ly produced for human consump tion. It should be ensured that imported insects comply 
with Union requirements for food and food safety . The additional requirements laid down in this Regulation for 
the entr y into the Union of consignments of products of animal origin should theref ore also apply to 
insects. Insects may also be subject to author isation as novel food in accordance with Regulation (EU) 2015/2283 
of the European Parliament and of the Council (12). 
(8)  On 18 October 2007, the European Food Safety Author ity adop ted an Opinion on the public health risks 
involved in the human consum ption of reptile meat (13). A number of hazards such as Salmonella and Trichinella 
were identif ied. Requirements for the entr y into the Union should include verification of compl iance with Union 
requirements to reduce the risk from these hazards in consignments of reptile meat. 17.5.2019 L 131/19 Official Jour nal of the European Union EN     
(6)Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 Apr il 2004 laying down specific hygiene rules for 
food of animal origin (OJ L 139, 30.4.2004, p. 55). 
(7)Commission Delegat ed Regulation (EU) 2019/624, of 8 Febr uary 2018 concer ning specific rules for the perfor mance of official 
controls on the production of meat and for production and relaying areas of live bivalve molluscs in accordance with Regulation 
(EU) 2017/625 of the European Parliament and of the Council (see page 1 of this Offi cial Jour nal). 
(8)Commission Implementing Regulation (EU) 2019/627 of 15 March 2019 laying down unif orm practical arrangements for the 
perf ormance of official controls on products of animal origin inten ded for human consump tion in accordance with Regulation 
(EU) 2017/625 of the European Parliament and of the Council and amending Commission Regulation (EC) No 2074/2005 as regards 
official controls (see page 51 of this Offi cial Jour nal). 
(9)Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 Apr il 2004 laying down specific rules for the 
orga nisation of official controls on products of animal origin intended for human consump tion (OJ L 139, 30.4.2004, p. 206). 
(10)Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 Apr il 2004 on official controls perfor med to ensure 
the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1). 
(11)Commission Regulation (EU) 2017/185 of 2 Febr uary 2017 laying down transitional measures for the application of certain provisions 
of Regulations (EC) No 853/2004 and (EC) No 854/2004 of the European Parliament and the Council (OJ L 29, 3.2.2017, p. 21). 
(12)Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending 
Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the 
European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1). 
(13)http://www .efsa.europa.eu/en/efsajournal/ pub/578 (9)  The composition of compo site products affect s the physico-c hemical charact eristics of such foods, leading to 
diffe rent risks. For this reason, only consignments of composit e products which compl y with applicable 
requirements, notably on the origin of the processed products of animal origin that compo se such foods, the 
origin of the food itself, or the guarant ees that accompan y the consignments of compo site products, should be 
author ised for entr y into the Union. For compo site products that pose a low risk to human health, this 
Regulation should provid e for derogations from checks at the border control posts. 
(10)  When laying down requirements for the entr y into the Union of consignments of certain animals and good 
intende d for human consum ption, referen ce should be made to the Combined Nomenclature codes in accordance 
with Council Regulation (EEC) No 2658/87 (14) to clearly identify these goods and animals. 
(11)  Consignments of certain animals and goods intended for human consump tion should only be allowed to enter 
the Union, based on a risk analysis, when the third countr ies or regions thereof from whic h these animals and 
goods originate , can ensure compl iance with the requirements on the safety of these animals and goods intende d 
for human consum ption and are duly listed in Commission Imp lementing Regulation (EU) 2019/626 (15). 
(12)  In addition to the requirements in Article 127(3) of Regulation (EU) 2017/625, specif ic requirements should be 
laid down for certain animals and goods intende d for human consump tion in order to provide guarantees as 
regar ds the efficiencies of official controls on food safety in third countr ies or regions thereof. Third countr ies or 
regions thereof should only appear on lists after evidence and guarant ees have been provi ded that the animals 
and goods concer ned from the third countr ies or regions thereof compl y with Union requirements for the safety 
of food, or with requirements recognised to be equivalent thereto, laid down in Directive 96/23/EC, Regulations 
(EC) No 999/2001, (EC) No 178/2002, (EC) No 852/2004, (EC) No 853/2004, (EU) 2017/625, and Delegat ed 
Regulation (EU) 2019/624 and Imple menting Regulation (EU) 2019/627. 
(13)  Consignments of certain goods intended for human consum ption should only be allowed to enter the Union 
where those goods are dispatche d from, and obtained or prepared in, establishments which appear on lists drawn 
up and kept up to date in accordance with Article 127(3)(e) of Regulation (EU) 2017/625. In addition, in order 
to ensure compl iance with Union food hygi ene rules, or with rules recognised to be at least equivalent thereto, it 
is appropr iate to provide that when drawing up and updating the lists of such establishments refer red to in 
Article 127(3)(e) of Regulation (EU) 2017/625, the third countr y should give guarant ees in addition those 
referred to in Article 127(3)(e)(i) and (iv) of Regulation (EU) 2017/625. 
(14)  The Commission should make the lists of establishments provided for in Article 127 of Regulation 
(EU) 2017/625 available to the public to ensure transparency for food business operators and consumers as 
regar ds whic h establishments such goods may enter the Union for placing on the market. With a view to ensure 
the effectiveness of these requirements, Member States should allow the entr y of consignments of such goods 
provid ed that the official certificates which are required to accompan y such consignments pursuant to the 
applicable Union rules are issued by the compet ent author ities of the third countr y starting with the date of 
publication by the Commission of the lists. 
(15)  Such requirements concer ning establishments should not be established in relation to goods intended for transit, 
since they represent a low risk from a food safety perspective and there is no placing on the mark et of animals 
and goods within the Union. In addition, such requirements should not be established for establishments carrying 
out only primar y production activities, transpor t operations, storage of products of animal origin not requir ing 
temperature-controlled storag e conditions or production of highly refined chondroitin sulphat e, hyaluronic acid, 
other hydrolysed cartilage products, chitosan, glucosamine, rennet, ising lass and amino acids referred to in 
Section XVI of Annex III to Regulation (EC) No 853/2004. 17.5.2019 L 131/20 Official Jour nal of the European Union EN     
(14)Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Cust oms Tariff 
(OJ L 256, 7.9.1987, p. 1). 
(15)Commission Implementing Regulation (EU) 2019/626 of 5 March 2019 concer ning lists of third countr ies or regions thereof 
author ised for the entr y into the European Union of certain animals and goods intended for human consump tion and amending 
Implementing Regulation (EU) 2016/759 as regards these lists (see page 31 of this Official Jour nal). (16)  Commission Regulation (EU) No 210/2013 (16) requires establishments producing sprouts to be approved by the 
compet ent author ities in accordance with Article 6 of Regulation (EC) No 852/2004. In order to ensure 
compl iance with Union food hygiene rules, or with rules recognised to be at least equivalent theret o, sprouts 
should only be allowed entr y to the Union if they are produced in establishments, whic h appear on lists 
drawn-up and updated in accordance with this Regulation. 
(17)  In order to ensure compliance with Union food hygi ene rules, or with rules recognised to be at least equivalent 
thereto, products from establishments manufact uring fresh meat, minced meat, meat preparations, meat 
products, mech anically separated meat and raw mat erials intende d for the production of gelatine and collagen , 
should only be allowed entr y into the Union if these establishments appear on lists drawn-up and updated in 
accordance with Article 127(3)(e) of Regulation (EU) 2017/625 and which are published by the Commission. In 
addition, the raw mater ials these products are manufactured from, should come from establishments (slaughter ­
houses, gam e-handling establishments, cutting plants and establishments handling fisher y products) appear ing on 
lists drawn up and updat ed in accordance with Article 127(3)(e) of Regulation (EU) 2017/625 and whic h are 
published by the Commission. 
(18)  Consignments of live bivalve molluscs, echinoder ms, tunicates and mar ine gastropods should only be allowe d 
entr y into the Union from production areas in third countr ies or regions thereof that appear on lists drawn up 
and updated in accordance with Article 127(3)(e) of Regulation (EU) 2017/625 and which are published by the 
Commission, in order to ensure compl iance with the applicable specifi c requirements for these products laid 
down in Regulation (EC) No 853/2004 and Implementing Regulation (EU) 2019/627, or with rules recognised to 
be at least equivalent thereto. The publication of those lists should ensure transparency for food business 
operat ors and consumers as regards from which production areas live bivalve molluscs, echinoder ms, tunicat es 
and mar ine gastropods may enter the Union. 
(19)  Consignments of fisher y products should only be allowed entr y into the Union when the consignments are 
dispatch ed from, obtained or prepared in an on-land establishment, reefe r, factory or freezer vessels flying the 
flag of a third countr y that appears on lists drawn up and updated in accordance with Article 127(3)(e) of 
Regulation (EU) 2017/625 and which are published by the Commission, in order to ensure compl iance with 
Union requirements, in particular with the specific requirements for fisher y products laid down in Regulation 
(EC) No 853/2004 and Implementing Regulation (EU) 2019/627, or with rules recognised to be at least 
equivalent thereto. The publication of such lists should ensure transparency for food business operat ors and 
consumers as regards the vessels from which fisher y products may enter the Union. 
(20)  The conditions for entr y into the Union of products of animal origin laid down in Regulation (EC) No 853/2004 
do not apply to compo site products. Howe ver, that Regulation requires the food business operat ors importing 
compo site products to ensure that the processed products of animal origin contained in such foods satisfy the 
requirements laid down in that Regulation. 
(21)  The risk related to the compo site products depends on the type of ingredients and on their storag e 
conditions. Requirements concer ning the consignments of compo site products should theref ore be laid down 
in order to ensure that those compo site products presenting a risk be expor ted from countr ies whic h are 
author ised to expor t to the Union pursuant to Commission Decision 2007/777/EC (17), Commission Decision 
2006/766/EC (18), Commission Regulation (EC) No 798/2008 (19), Commission Regulation (EU) No 605/2010 (20) 
and Commission Decision 2011/163/EU (21). 17.5.2019 L 131/21 Official Jour nal of the European Union EN     
(16)Commission Regulation (EU) No 210/2013 of 11 March 2013 on the approval of establishments producing sprouts pursuant to 
Regulation (EC) No 852/2004 of the European Parliament and of the Council (OJ L 68, 12.3.2013, p. 24). 
(17)Commission Decision 2007/777/EC of 29 November 2007 laying down the animal and public health conditions and model certificates 
for impor ts of certain meat products and treated stomac hs, bladders and intest ines for human consump tion from third countr ies and 
repealing Decision 2005/432/EC (OJ L 312, 30.11.2007, p. 49). 
(18)Commission Decision 2006/766/EC of 6 November 2006 establishing the lists of third countr ies and territories from whic h impor ts of 
bivalve molluscs, echinoderms, tunicates, mar ine gastr opods and fisher y products are permitted (OJ L 320, 18.11.2006, p. 53). 
(19)Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countr ies, territories, zones or compar tments 
from whic h poultr y and poultr y products may be impor ted into and transit through the Community and the veterinar y certification 
requirements (OJ L 226, 23.8.2008, p. 1). 
(20)Commission Regulation (EU) No 605/2010 of 2 July 2010 laying down animal and public health and veterinar y certification conditions 
for the introduction into the European Union of raw milk, dair y products, colostr um and colostr um-based products intended for 
human consump tion (OJ L 175, 10.7.2010, p. 1). 
(21)Commission Decision 2011/163/EU of 16 March 2011 on the approval of plans submitted by third countr ies in accordance with 
Article 29 of Council Directive 96/23/EC (OJ L 70, 17.3.2011, p. 40). (22)  Based on the number of notifications received in the Rapid Aler t System for Food and Feed established by 
Regulation (EC) No 178/2002, consignments of certain animals and goods placed on the mark et for human 
consum ption present an enhanced risk for non-comp liance with Union requirements on food safety . 
Consignments of such animals and goods placed on the mark et for human consump tion should theref ore be 
subject to the individual certification of each consignment for entr y into the Union for placing on the mark et. 
Certification of compl iance with Union requirements may also contr ibute to reminding food business operators 
and the compet ent author ities of third countr ies or regions thereof of the applicable Union requirements. In the 
case of transit, the use of the current dedicate d transit certificates with animal health attestation should remain. 
(23)  As Regulation (EU) 2017/625 applies with effect from 14 December 2019, this Regulation should also apply 
from that date. Transitional measures providing derogations from Regulations (EC) No 853/2004 and (EC) 
No 854/2004, concer ning public health requirements for the imports of compo site products have been laid 
down in Regulation (EU) 2017/185 and will be exte nded until 20 Apr il 2021 in accordance with Commission 
Regulation (EU) 2019/759 (22). The impor t requirements laid down in this Regulation should theref ore apply 
from 20 Apr il 2021 for composit e products in order to ensure a smooth transition, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Subject matter and scope 
1. This Regulation supplements Regulation (EU) 2017/625 as regards the requirements for the entr y in the Union of 
consignments of certain animals and goods intended for human consum ption from third countr ies or regions thereof in 
order to ensure that they compl y with the applicable requirements established by the rules refer red to in Article 1(2)(a) 
of Regulation (EU) 2017/625 or with requirements recognised to be at least equivalent theret o. 
2. The requirements refer red to in paragraph 1 cover: 
(a)  the identif ication of animals and goods subject to the following requirements for entr y into the Union: 
(i)  the requirement that those animals and goods shall come from a third countr y or region thereof listed in 
accordance with Article 126(2)(a) of Regulation (EU) 2017/625; 
(ii)  the requirement that those animals and goods be dispatch ed from, and obtained or prepared in, establishments 
whic h comply with applicable requirements refer red to in Article 126(1) of Regulation (EU) 2017/625, or with 
requirements recognised to be at least equivalent thereto, and which appear on lists drawn-up and updat ed in 
accordance with Article 127(3)(e)(ii) and (iii) of Regulation (EU) 2017/625; 
(iii)  the requirement that each consignment of animals and goods be accompan ied by an official certificate, or 
official attes tation or any other evidence of compliance with the rules referred to in Article 1(2)(a) of Regulation 
(EU) 2017/625, such a as private attestation, in accordance with Article 126(2)(c) of Regulation (EU) 2017/625; 
(b)  requirements for the entr y into the Union of certain animals and goods from a third countr y or region thereof, 
liste d in accordance with Article 127(2) of Regulation (EU) 2017/625; 
(c)  requirements that consignments of certain goods from third countr ies be dispatche d from, and obtained or prepared 
in, establishments which comply with the applicable requirements refer red to in Article 126(1) of Regulation 
(EU) 2017/625, or with requirements recognised to be at least equivalent thereto, and which appear on lists 
drawn-up and updat ed in accordance with Article 127(3)(e)(ii)and (iii) of Regulation (EU) 2017/625; 
(d)  requirements for the entr y into the Union for placing on the market of the specific follo wing commodities in 
addition to the requirements laid down in accordance with Article 126 of Regulation (EU) 2017/625: 
(i)  fresh meat, minced meat, meat preparations, meat products, mech anically separated meat and raw mate rials 
intende d for the production of gelatine and collagen ; 17.5.2019 L 131/22 Official Jour nal of the European Union EN     
(22)Commission Regulation (EU) 2019/759 of 13 May 2019 laying down transitional measures for the application of public health 
requirements of impor ts of food containing both products of plant origin and processed products of animal origin (composit e products) 
(OJ L 125, 14.5.2019, p. 11). (ii)  live bivalve molluscs, echinoder ms, tunicate s and mar ine gastropods; 
(iii)  fisher y products; 
(iv)  compo site products; 
(e)  additional requirements for the official certificates, official attestations and private attestations that shall accompan y 
certain animals and goods for entr y into the Union. 
3. This Regulation shall not apply to: 
(a)  Animals and goods not intended for human consum ption, however when the destination of the animals and goods 
has not been decided at entr y into the Union, this Regulation applies; 
(b)  Animals and goods intended for human consump tion only for transit through the Union without being placed on 
the market. 
Article 2 
Def initions 
For the purpose of this Regulation, the followi ng definit ions shall apply:  
(1) ‘equivalent’ means equivalent as defined in Article 2(1)(e) of Regulation (EC) No 852/2004;  
(2) ‘placing on the market’ means placing on the market as defined in point (8) of Article 3 of Regulation (EC) 
No 178/2002;  
(3) ‘establishment’ means an establishment as defined in Article 2(1)(c) of Regulation (EC) No 852/2004;  
(4) ‘private attestation’ means an attestation signed by the importing food business operator;  
(5) ‘fresh meat’ means fresh meat as defined in point 1.10 of Annex I to Regulation (EC) No 853/2004;  
(6) ‘minced meat’ means minced meat as defined in point 1.13 of Annex I to Regulation (EC) No 853/2004;  
(7) ‘meat preparations’ means meat preparations as defined in point 1.15 of Annex I to Regulation (EC) No 853/2004;  
(8) ‘meat products’ means meat products as defined in point 7.1 of Annex I to Regulation (EC) No 853/2004;  
(9) ‘mec hanically separated meat’ means mechanically separated meat as defined in point 1.14 of Annex I to 
Regulation (EC) No 853/2004;  
(10) ‘gelat ine’ means gelatine as defined in point 7.7 of Annex I to Regulation (EC) No 853/2004;  
(11) ‘collag en’ means collagen as defined in point 7.8 of Annex I to Regulation (EC) No 853/2004;  
(12) ‘bivalve molluscs’ means bivalve molluscs as defined in point 2.1 of Annex I to Regulation (EC) No 853/2004;  
(13) ‘fisher y products’ means fisher y products as defined in point 3.1 of Annex I to Regulation (EC) No 853/2004;  
(14) ‘com posite product’ means food containing both products of plant origin and processed products of animal origin;  
(15) ‘rept iles’ means animals belonging to the species Allig ator mississippiensis, Crocodylus johnstoni, Crocodylus niloticus, 
Crocodylus poro sus, Timon Lepidus, Python reticulatus, Python molur us bivittatus or Pelodiscus sinensis;  
(16) ‘rept ile meat’ means the edible parts, either unprocessed or processed, derived from farmed reptiles, which are, 
when applicable, author ised in accordance with Regulation (EU) 2015/2283 and listed in Commission 
Implementing Regulation (EU) 2017/2470 (23); 17.5.2019 L 131/23 Official Jour nal of the European Union EN     
(23)Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance 
with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel food (OJ L 351, 30.12.2017, p. 72). (17) ‘insects’ means food consisting of, isolate d from or produced from insects or their parts including any life stadia of 
insects intended for human consump tion whic h are, when applicable, author ised in accordance with Regulation 
(EU) 2015/2283 and listed in Implementing Regulation (EU) 2017/2470;  
(18) ‘sprouts’ means sprouts as defined in point (a) of Article 2 of Commission Implementing Regulation (EU) 
No 208/2013 (24);  
(19) ‘primar y production’ means primar y production as defined in point (17) of Article 3 of Regulation (EC) 
No 178/2002;  
(20) ‘slaught erhouse ’ means a slaughterhous e as defined in point 1.16 of Annex I to Regulation (EC) No 853/2004;  
(21) ‘gam e-handling establishment’ means a gam e-handling establishment as defined in point 1.18 of Annex I to 
Regulation (EC) No 853/2004;  
(22) ‘cutting plant’ means a cutting plant as defined in point 1.17 of Annex I to Regulation (EC) No 853/2004;  
(23) ‘production area’ means a production area as defined in point 2.5 of Annex I to Regulation (EC) No 853/2004;  
(24) ‘factor y vessel’ means a factor y vessel as defined in point 3.2 of Annex I to Regulation (EC) No 853/2004;  
(25) ‘freezer vessel’ means a freezer vessel as defined in point 3.3 of Annex I to Regulation (EC) No 853/2004;  
(26) ‘reefe r vessel’ means a vessel equipped to store and transpor t palletized or loose cargo (bulk) goods in temperature 
controlled holds or chambers;  
(27) ‘food business operat or’ means a food business operator as defined in point (3) of Article 3 of Regulation (EC) 
No 178/2002. 
Article 3 
Animals and goods which are required to come from third countr ies or regions thereof included 
in the list refer red to in Article 126(2)(a) of Regulation (EU) 2017/625 
Consignments of the followi ng animals and goods intended for human consum ption shall enter the Union only from 
a third countr y or region thereof included in the list for those animals and goods laid down in Articles 3 to 22 of 
Implementing Regulation (EU) 2019/626: 
(a)  products of animal origin, including reptile meat and dead whole insects, parts of insects or processed insects, for 
which Combined Nomenclature codes (‘CN codes’) have been laid down in Chapt ers 2 to 5, 15 and 16, and 
Harmonised System codes (‘HS codes ’) under headings 1702, 1806, 2102, 2103, 2105, 2106, 2202, 2301, 2822, 
2932, 3001, 3002, 3501, 3502, 3503, 3504, 3507, 3913, 4101, 4102, 4103, 4110 and 9602 of Part Two of 
Annex I to Regulation (EEC) No 2658/87, when these products are intended for human consump tion; 
(b)  live insects referred to by the CN code 0106 49 00 of Part Two of Annex I to Regulation (EEC) No 2658/87. 
Article 4 
Addition al requirements for entr y into the Union of certain animals and goods from a third 
countr y or region thereof 
In addition to the requirements laid down in Article 127(3) of Regulation (EU) 2017/625, the Commission shall only 
decide on the inclusion of third countr ies or regions thereof in the list referred to in Article 126(2)(a) of that Regulation 
if the follo wing requirements are recognised by the Commission as being at least equivalent to the relevant requirements 
in the Union for animals and goods refer red to in Article 3: 
(a)  the legislation of the third countr y on: 
(i)  the production of food of animal origin; 17.5.2019 L 131/24 Official Jour nal of the European Union EN     
(24)Commission Implementing Regulation (EU) No 208/2013 of 11 March 2013 on traceability requirements for sprouts and seeds 
inten ded for the production of sprouts (OJ L 68, 12.3.2013, p. 16). (ii)  the use of veterinar y medicinal products, including rules on their prohibition or author isation, their distr ibution, 
their placing on the market and the rules cover ing administration and inspection; 
(iii)  the preparation and use of feed, including the procedures for using additives and the preparation and use of 
medicate d feedingstuffs, as well as the hygiene quality of the raw mater ials used for prepar ing feedingstuffs and 
of the final product ; 
(b)  the hygiene conditions of production, manufact ure, handling, storage and dispatch currently applied to products of 
animal origin destined for the Union; 
(c)  any exper ience of mark eting of the products of animal origin from the third countr y and the results of any official 
controls on entr y in the Union; 
(d)  when available, the results of controls carried out by the Commission in the third countr y related to other animals 
and goods for whic h the third countr y is already listed in accordance with Article 127(2) of Regulation 
(EU) 2017/625, in particular the results of the assessment of the compet ent author ities in the third countr y audited, 
and the action that the compet ent author ities have take n in the light of any recommendations addressed to them 
followi ng such audits by the Commission; 
(e)  the existen ce, implementation and communication of a zoonoses control programme approved by the Commission 
when applicable; 
(f)  the existen ce, imple mentation and communication of a residues control programme approved by the Commission 
when applicable, in accordance with Directive 96/23/EC. 
Article 5 
Requirements for entr y into the Union of certain goods from a third countr y in relation to 
establishments 
1. Consignments of the follo wing goods shall only enter the Union where those consignments are dispatched from, 
and obtained or prepared in, establishments that appear on lists drawn up and kept up-to-dat e in accordance with 
Article 127(3)(e)(ii) and (iii) of Regulation (EU) 2017/625: 
(a)  products of animal origin for whic h requirements are laid down in Annex III to Regulation (EC) No 853/2004, and 
for which CN codes have been laid down in Chapt ers 2 to 5, 15 and 16, and HS codes under headings 2102, 2103, 
2105, 2106, 2202, 2301, 2822, 2932, 3001, 3002, 3501, 3502, 3503, 3504, 3507, 3913, 4101, 4102, 4103 
and 4110 of Part Two of Annex I to Regulation (EEC) No 2658/87; 
(b)  sprouts refer red to by the followi ng HS codes: 0704 90, 0706 90, 0708 10, 0708 20, 0708 90 or 1214 90 of 
Part Two of Annex I to Regulation (EEC) No 2658/87. 
2. Establishments referred to in paragraph 1 of this Article may be placed on the lists refer red to in Article 127(3)(e) 
of Regulation (EU) 2017/625 only if, in addition to the guarant ees laid down in Article 127(3)(e)(ii) and (iv) of 
Regulation (EU) 2017/625, the third countr y gives the follo wing guarantees: 
(a)  such establishments, together with any establishments handling raw mater ial of animal origin used in the 
manufacture of the products of animal origin concer ned, comply with applicable requirements referred to in 
Article 126(1) of Regulation (EU) 2017/625, in particular those of Regulation (EC) No 853/2004, or with 
requirements recognised to be at least equivalent thereto; 
(b)  the establishment, where appropr iate, only handles raw mater ials of animal origin that come from third countr ies 
with an approved residues monitoring plan for that product cate gory in accordance with Directive 96/23/EC or 
from Member State s; 
(c)  it has real powers to stop the establishments from expor ting to the Union in the event that the establishments fail to 
meet the relevant Union requirements or requirements recognised to be at least equivalent theret o. 
3. The Commission shall provid e the Member States with any new and updat ed lists that it receives from the 
compet ent author ities of the third countr y in accordance with Article 127(3)(e)(iii) of Regulation (EU) 2017/625 and 
shall publish such lists on its website. 
4. Member States shall allow the entr y into the Union of the consignments refer red to in paragraph 1 provi ded that 
the official certificates whic h are required to accompan y such consignments pursuant to the applicable Union rules are 
issued by the compet ent author ities of the third countr y starting with the date of publication by the Commission of the 
lists referred to in paragraph 1. 17.5.2019 L 131/25 Official Jour nal of the European Union EN     Article 6 
Establishments not subject to the requirements of Article 5(1) 
The requirements laid down in Article 5 shall not apply to establishments that only carry out the following activities: 
(a)  primar y production; 
(b)  transpor t operations; 
(c)  storag e of products of animal origin not requir ing temperature-controlled storag e conditions;. 
(d)  production of highly refined chondroitin sulphate, hyaluronic acid, other hydrolysed cartilage products, chitosan, 
glucosamine, rennet, ising lass and amino acids refer red to in Section XVI of Annex III to Regulation (EC) 
No 853/2004 and referred to by the CN codes under the heading of 2833, ex 3913, 2930, ex 2932, 3507 or 3503 
of Part Two of Annex I to Regulation (EEC) No 2658/87. 
Article 7 
Requirements for consignments of fresh meat, minced meat, meat preparations, meat products, 
mechanically separated meat and raw mater ials intended for the production of gelatine and 
collagen 
Consignments of the follo wing products of animal origin shall only enter the Union if they have been manufactured 
from raw mat erials obtained in slaughter houses, game-handling establishments, cutting plants and establishments 
handling fisher y products, appear ing on lists of establishments drawn up and kept up-to-dat e in accordance with 
Article 127(3)(e) of Regulation (EU) 2017/625: 
(a)  fresh meat ; 
(b)  minced meat ; 
(c)  meat preparations; 
(d).  meat products and mechanically separated meat ; 
(e)  raw mater ials intended for the production of gelatine and collage n referred to respectively in point 4(a) of Chapt er I 
of Section XIV and in point 4(a) of Chapt er I of section XV of Annex III to Regulation (EC) No 853/2004. 
Article 8 
Requirements for consignments of live bivalv e molluscs, echinoder ms, tunicates and mar ine 
gastropods 
1. Notwithstanding Article 6, consignments of live bivalve molluscs, echi noder ms, tunicate s and mar ine gastropods 
for whic h CN codes have been laid down in heading 0307 of Part Two of Annex I to Regulation (EEC) No 2658/87 
shall enter the Union only from production areas in third countr ies that appear on lists drawn up by the compet ent 
author ities of the third countr y in accordance with Article 127(3)(e) of Regulation (EU) 2017/625 and published by the 
Commission. 
2. The following products may enter the Union from production areas which have not been classified by the 
compet ent author ities in the third countr y in accordance with Article 18(6) of Regulation (EU) 2017/625: 
(a)  Pectinidae, excep t where data from official monitori ng programmes as established by Article 57 of Implementing 
Regulation (EU) 2019/627 enable the compet ent author ities to classify fishing grounds as set out in point (2) of 
Chapt er IX of Section VII of Annex III to Regulation (EC) No 853/2004; 
(b)  mar ine gastropods that are not filter feeders and Holothuro idea that are not filter feeders. 17.5.2019 L 131/26 Official Jour nal of the European Union EN     Article 9 
Listing of production areas 
1. Before the lists refer red to in Article 8(1) are drawn up by the compet ent author ities of the third countr y, 
particular account shall be take n of the guarant ees that the compet ent author ities of the third countr y can give 
concer ning compliance with the requirements of Article 52 of Imp lementing Regulation (EU) 2019/627 on the classifi ­
cation and control of production areas. 
The Commission shall carry out an on-the-spot control visit before such lists are drawn up. 
2. Once lists refer red to in Article 8(1) are drawn up, and when the compet ent author ities of the third countr y offer 
suffi cient guarant ees on the management and controls of production areas under their responsibility , the on-the-spot 
Commission control visit need not to be carried out prior to the addition of a new production area to an existing list 
established in accordance with Article 5. 
Article 10 
Special requirements for fisher y products 
Consignments of fisher y products for which CN codes have been laid down in headings 0301, 0302, 0303, 0304, 
0305, 0306, 0307, 0308, 1504, 1516, 1603, 1604, 1605 or 2106 of Part Two of Annex I to Regulation (EEC) 
No 2658/87, shall enter the Union for placing on the market only if they have been obtained or prepared, at any stage 
of their production, in an on-land establishment, a factor y or freezer vessel or stored in a cold-stor e or a reefer vessel 
that appears on a list drawn up and updated in accordance with Article 127(3)(e) of Regulation (EU) 2017/625 and 
published by the Commission. 
Article 11 
1. A vessel may be included on the lists of establishments refer red to in Article 127(3)(e)(ii) of Regulation 
(EU) 2017/625 provid ed that the compe tent author ities of the third countr y the flag of which the vessel is flying and 
the compet ent author ities of another third countr y to whic h the compet ent author ities of the third countr y the flag of 
whic h the vessel is flying have delegat ed responsibility for the inspection of the vessel concer ned, provid e the 
Commission with a joint communication stating that all four of the follo wing requirements are met: 
(a)  both third countr ies appear on the list of third countr ies or regions thereof, drawn up in accordance with 
Article 127(3) of Regulation (EU) 2017/625, from whic h entr y into the Union of fisher y products is permitted ; 
(b)  all fisher y products from the vessel concer ned that are destined for placing on the market in the Union are 
landed directly in the third countr y to whic h the third countr y the flag of whic h the vessel is flying has delega ted 
responsibility for the inspection of the vessels concer ned; 
(c)  the delegat ed compet ent author ities have inspect ed the vessel and have declared that it compl ies with the applicable 
Union requirements; 
(d)  the delegat ed compet ent author ities have declared that they will regularly inspect the vessel to ensure that it 
continues to compl y with the applicable Union requirements. 
2. A vessel may be included on the lists of establishments refer red to in Article 127(3) of Regulation (EU) 2017/625 
on the basis of a joint communication from the compet ent author ities of the third countr y the flag of which the vessel 
is flying and from the compet ent author ities of a Member State, to whic h the compet ent author ities of the third countr y 
the flag of which the vessel is flying have delegat ed responsibility for the inspection of the vessel concer ned, if all three 
of the following requirements are met : 
(a)  all fisher y products from the vessel concer ned that are destined for placing on the market in the Union are landed 
directly in that Member State ; 
(b)  the compet ent author ities of that Member State have inspect ed the vessel and have declared that it compl ies with the 
applicable Union requirements; 
(c)  the compet ent author ities of that Member State have declared that they will regularly inspect the vessel to ensure 
that it continues to compl y with the applicable Union requirements. 17.5.2019 L 131/27 Official Jour nal of the European Union EN     3. When consignments of fisher y products enter the Union directly from a reefer , factor y or a freezer vessel flying 
the flag of a third countr y, the official certificate refer red to in Article 13(3) of Commission Implementing Regulation 
(EU) 2019/628 (25) may be signed by the captai n. 
Article 12 
Requirements for consignments of composite products 
1. Consignments of compo site products refer red to by the HS codes under headings 1601, 1602, 1603, 1604, 1605, 
1901, 1902, 1905, 2004, 2005, 2103, 2104, 2105, 2106 of Part Two of Annex I to Regulation (EEC) No 2658/87 
shall enter the Union for placing on the mark et only if each processed product of animal origin contained in the 
compo site products was either produced in establishments that are located in third countr ies or regions thereof and 
author ised to expor t those processed products of animal origin to the Union in accordance with Article 5 or in 
establishments locat ed in Member States. 
2. Pending the establishment by the Commission of a specif ic list of third countr ies or regions thereof author ised to 
expor t compo site products to the Union, consignments of compo site products from third countr ies or regions thereof 
may enter into the Union, subject to compl iance with the follo wing rules: 
(a)  compo site products refer red to in paragraph 1 that need to be transpor ted or stored under controlled temperatures 
shall originate from third countr ies or regions thereof author ised to expor t each processed product of animal origin 
contained in the final product to the Union, pursuant to Commission Decision 2007/777/EC, Commission 
Regulation (EU) No 605/2010, Commission Decision 2006/766/EC, Commission Regulation (EC) No 798/2008 and 
Decision 2011/163/EU; 
(b)  compo site products refer red to in paragraph 1 that do not need to be transpor ted or stored under controlled 
temperatures containing any quantity of processed meat shall originate from third countr ies or regions thereof 
author ised to expor t to the Union the meat products contained in the compo site product pursuant to Commission 
Decision 2007/777/EC and Commission Decision 2011/163/EU; 
(c)  compo site products refer red to in paragraph 1 that do not need to be transpor ted or stored under controlled 
temperatures and which contain processed products of animal origin other than processed meat, for whic h 
requirements are laid down in Annex III to Regulation (EC) No 853/2004 shall originate from third countr ies or 
regions thereof author ised to expor t meat products, dair y products, colostr um-based products, fisher y products or 
egg products to the Union on the basis of the Union animal and public health requirements and whic h are listed at 
least for one of these products of animal origin pursuant to Commission Decision 2007/777/EC, Commission 
Regulation (EU) No 605/2010, Commission Decision 2006/766/EC and Commission Regulation (EC) No 798/2008, 
and in the annex to Commission Decision 2011/163/EU on the basis of a residues control plan approved in 
accordance with Directive 96/23/EC. 
Article 13 
Official certificates 
1. Each consignment of the followi ng products shall enter the Union only where the consignment is accompanied by 
an official certificate: 
(a)  products of animal origin for whic h CN codes have been laid down in Chapt ers 2 to 5, 15 and 16, and HS codes 
under headings 1506, 1521, 1601, 1602, 1603, 1604, 1605, 2102, 2103, 2105, 2106, 2202, 2301, 2932, 3001, 
3002, 3501, 3502, 3503, 3504, 3507, 3913, 4101, 4102, 4103, 4110 and 9602 of Part Two of Annex I to 
Regulation (EEC) No 2658/87, when these products are intended for human consump tion; 
(b)  live insects referred to by the CN code 0106 49 00 of Part Two of Annex I to Regulation (EEC) No 2658/87; 
(c)  sprouts and seeds intended for the production of sprouts and refer red to by the following HS codes: 0704 90, 
0706 90, 0708 10, 0708 20, 0708 90, 0713 10, 0713 33, 0712 34, 0712 35, 0713 39, 0713 40, 0712 50, 
0712 60, 0713 90, 0910 99, 1201 10, 1201 90, 1207 50, 1207 99, 1209 10, 1209 21, 1209 91 or 1214 90 of 
Part Two of Annex I to Regulation (EEC) No 2658/87. 17.5.2019 L 131/28 Official Jour nal of the European Union EN     
(25)Commission Implementin g Regulation (EU) 2019/628 of 8 Apr il 2019 concer ning model official certificates for certain animals and 
goods and amending Regulation (EC) No 2074/2005 and Implementing Regulation (EU) 2016/759 as regards these model certificates 
(see page 101 of this Offi cial Jour nal). 2. The official certificates referred to in paragraph 1 shall certify that the products compl y with: 
(a)  the requirements laid down in Regulations (EC) No 178/2002, (EC) No 852/2004 and (EC) No 853/2004 or 
provisions recognised to be equivalent to those requirements; 
(b)  any specific requirements for entr y into the Union set out in this Regulation. 
3. The official certificates refer red to in paragraph 1 may include details required in accordance with other Union 
legislation on public and animal health matters. 
4. The official certificate for sprouts and seeds intended for the production of sprouts refer red to in paragraph 1(c), 
shall accompan y the consignment until it reach es its destination as indicated in the official certificate. In the case of 
splitting of the consignment, a copy of the official certificate shall accompan y each part of the consignment. 
Article 14 
Private attest ation 
1. A private attes tation, prepared and signed by the impor ting food business operat or, shall accompan y the 
consignments of composit e products as refer red to in Article 12(2)(c) conf irming that the consignments comply with 
the applicable requirements refer red to in Article 126(1) of Regulation (EU) 2017/625. 
2. By way of derogation to paragraph 1, for the products exempted from official controls at border control posts, in 
accordance with Article 48(h) of Regulation (EU) 2017/625, the private attestation shall accompan y the products at the 
time of the placing on the mark et. 
3. The private attestation refer red to in paragraph 1 shall ensure the traceability of the consignment and shall include: 
(a)  information regarding the consignor and consignee of the imported goods; 
(b)  the list of products of plant origin and processed products of animal origin contained in the compo site products, 
indicated in descending order of weight, as recorded at the time of their use in the manufacture of the compo site 
product ; 
(c)  the approval number of the establishment(s) manuf actur ing the processed products of animal origin contained in the 
compo site product, as provid ed for in Article 4(2) of Regulation (EC) No 853/2004 and indicated by the impor ting 
food business operator . 
4. The private attestation refer red to in paragraph 1 shall attest that: 
(a)  the third countr y or region thereof producing the compo site product is listed at least for one of the following 
catego ry of product of animal origin: 
(i)  meat products; 
(ii)  dair y products or colostr um-based products; 
(iii)  fisher y products; 
(iv)  egg products; 
(b)  the establishment producing the composit e products fulfils hygiene standards, recognised to be equivalent to those 
required by Regulation (EC) No 852/2004; 
(c)  the compo site product does not need to be stored or transpor ted under controlled temperature; 
(d)  the processed products of animal origin contained in the composit e product originate from third countr ies or 
regions thereof author ised to expor t each processed product of animal origin to the Union, or from the Union, and 
are sourced from listed establishment(s); 
(e)  the processed products of animal origin used in the compo site product have undergone at least the treatment 
provid ed for those products pursuant to Commission Decision 2007/777/EC and Commission Regulation (EU) 
No 605/2010 with a brief descr iption of any processes undergone and temperatures applied to the product. 17.5.2019 L 131/29 Official Jour nal of the European Union EN     Article 15 
Entr y into force 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 
It shall apply from 14 December 2019. However , the requirements laid down in Article 12, and Article (14)(1) and (2) 
shall apply from 21 Apr il 2021. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 4 March 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  17.5.2019 L 131/30 Official Jour nal of the European Union EN